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A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'.

Kang HJ, Kim MK, Kim MG, Choi DJ, Yoon JH, Park YB, Kim HS - Trials (2011)

Bottom Line: Bone marrow derived stem/progenitor cell transplantation after acute myocardial infarction is safe and effective for improving left ventricular systolic function.However, the improvement of left ventricular systolic function is limited.The objectives of this study are to evaluate the safety and efficacy of combination cytokine therapy with erythropoietin and G-CSF (phase I) and repeated progenitor/stem cell treatment (phase II).

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 28 Yongon-dong, Jongno-gu, Seoul, Korea.

ABSTRACT

Background: Bone marrow derived stem/progenitor cell transplantation after acute myocardial infarction is safe and effective for improving left ventricular systolic function. However, the improvement of left ventricular systolic function is limited. This study will evaluate novel stem/progenitor cell therapy with combination cytokine treatment of the long-acting erythropoietin analogue, darbepoetin, and granulocyte colony-stimulating factor (G-CSF) in patients with acute myocardial infarction.

Methods: The 'MAGIC Cell-5-Combination Cytokine Trial' is a multicenter, prospective, randomized, 3-arm, controlled trial with blind evaluation of the endpoints. A total of 116 patients will randomly receive one of the following three treatments: an intravenous darbepoetin infusion and intracoronary infusion of peripheral blood stem cells mobilized with G-CSF (n = 58), an intracoronary infusion of peripheral blood stem cells mobilized with G-CSF alone (n = 29), or conventional therapy (n = 29) at phase I. Patients with left ventricular ejection fraction < 45% at 6 months, in the patients who received stem cell therapy at phase I, will receive repeated cell therapy at phase II. The objectives of this study are to evaluate the safety and efficacy of combination cytokine therapy with erythropoietin and G-CSF (phase I) and repeated progenitor/stem cell treatment (phase II).

Discussion: This is the first study to evaluate the safety and efficacy of combination cytokine based progenitor/stem cell treatment.

Trial registration: http://www.ClinicalTrials.gov identifier: NCT00501917.

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Related in: MedlinePlus

Flow chart demonstrating scheduling during the MAGIC Cell-5-Combination Cytokine Trial.
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Related In: Results  -  Collection

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Figure 1: Flow chart demonstrating scheduling during the MAGIC Cell-5-Combination Cytokine Trial.

Mentions: The 'MAGIC Cell-5-Combination Cytokine Trial' described here is a multicenter, prospective, randomized, 3-arm, controlled, phase 2 trial with blind evaluation of endpoints (Figure 1).


A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'.

Kang HJ, Kim MK, Kim MG, Choi DJ, Yoon JH, Park YB, Kim HS - Trials (2011)

Flow chart demonstrating scheduling during the MAGIC Cell-5-Combination Cytokine Trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3045901&req=5

Figure 1: Flow chart demonstrating scheduling during the MAGIC Cell-5-Combination Cytokine Trial.
Mentions: The 'MAGIC Cell-5-Combination Cytokine Trial' described here is a multicenter, prospective, randomized, 3-arm, controlled, phase 2 trial with blind evaluation of endpoints (Figure 1).

Bottom Line: Bone marrow derived stem/progenitor cell transplantation after acute myocardial infarction is safe and effective for improving left ventricular systolic function.However, the improvement of left ventricular systolic function is limited.The objectives of this study are to evaluate the safety and efficacy of combination cytokine therapy with erythropoietin and G-CSF (phase I) and repeated progenitor/stem cell treatment (phase II).

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, 28 Yongon-dong, Jongno-gu, Seoul, Korea.

ABSTRACT

Background: Bone marrow derived stem/progenitor cell transplantation after acute myocardial infarction is safe and effective for improving left ventricular systolic function. However, the improvement of left ventricular systolic function is limited. This study will evaluate novel stem/progenitor cell therapy with combination cytokine treatment of the long-acting erythropoietin analogue, darbepoetin, and granulocyte colony-stimulating factor (G-CSF) in patients with acute myocardial infarction.

Methods: The 'MAGIC Cell-5-Combination Cytokine Trial' is a multicenter, prospective, randomized, 3-arm, controlled trial with blind evaluation of the endpoints. A total of 116 patients will randomly receive one of the following three treatments: an intravenous darbepoetin infusion and intracoronary infusion of peripheral blood stem cells mobilized with G-CSF (n = 58), an intracoronary infusion of peripheral blood stem cells mobilized with G-CSF alone (n = 29), or conventional therapy (n = 29) at phase I. Patients with left ventricular ejection fraction < 45% at 6 months, in the patients who received stem cell therapy at phase I, will receive repeated cell therapy at phase II. The objectives of this study are to evaluate the safety and efficacy of combination cytokine therapy with erythropoietin and G-CSF (phase I) and repeated progenitor/stem cell treatment (phase II).

Discussion: This is the first study to evaluate the safety and efficacy of combination cytokine based progenitor/stem cell treatment.

Trial registration: http://www.ClinicalTrials.gov identifier: NCT00501917.

Show MeSH
Related in: MedlinePlus